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FDA NDA · NDA018976

LEVATOL

Sponsor: ENDO OPERATIONS

APPLICATION
NDA018976
TYPE
NDA
ORIGINAL APPROVAL
1987-12-30
LATEST ACTION
2011-05-03
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued

Products

LEVATOL · ReferenceDiscontinued
PENBUTOLOL SULFATE 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET · ORAL
LEVATOL · ReferenceDiscontinued
PENBUTOLOL SULFATE 20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET · ORAL

Approval history

2011-05-03Labeling · Supplement 12 · unknown — Label ↗AP
2001-02-06Labeling · Supplement 9 · standardAP
2000-09-25Manufacturing (CMC) · Supplement 8 · standardAP
1999-10-29Manufacturing (CMC) · Supplement 7 · standardAP
1996-06-07Manufacturing (CMC) · Supplement 6 · standardAP
1996-03-12Manufacturing (CMC) · Supplement 5 · standardAP
1993-09-15Manufacturing (CMC) · Supplement 4 · standardAP
1990-11-07Labeling · Supplement 3AP
1989-01-05Labeling · Supplement 2AP
1988-10-26Manufacturing (CMC) · Supplement 1 · standardAP
1987-12-30Type 1 - New Molecular Entity · Original · standardAP
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Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.

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